Funktionelle Nachsorge nach schließmuskelerhaltender tiefer anteriorer Rektumresektion

Several treatment options are available for the treatment of low anterior resection syndrome (LARS) after sphincter-preserving rectal resection; however, the real life application of these therapeutic options in the postoperative course of the patients is not known. There are no recommendations concerning a structured functional follow-up.

The aim of the study is to evaluate whether a structured functional follow-up can improve LARS symptoms and the quality of life.

In an open label prospective randomized trial 204 patients with both minor or major LARS documented 4 weeks after stoma reversal by curative low anterior resection of the rectum (LARR) for rectal cancer UICC stages I–III who have completed adjuvant therapy will be included in the trial. They will either be randomized into the standard of care arm which includes thorough education concerning the etiology and therapeutic options of LARS and the offer of consultation on demand, or into the experimental arm of intensive functional follow-up. These patients will be actively contacted every 3 months by the centers to evaluate LARS symptoms and to offer therapeutic options according to the symptoms of individual patients. The therapeutic recommendations will be given according to the choice of the individual centers. The primary endpoint is the quality of life documented with the EORTC QLQ-C30 questionnaire. The LARS score and the adherence to therapeutic recommendations are secondary endpoints. Psycho-oncological aspects regarding anxiety, depression and distress will be recorded as exploratory parameters. The study is accredited by the German Cancer Society (Deutsche Krebsgesellschaft) in the StudyBox and registered in the German registry for clinical trials (DRKS00033615).